Poster Session

P98. Use of a coriolus versicolor-based vaginal gel in patients with precancerous hpv lesions. Interim analysis results

Andres Carlos Lopez (ES), Luis Serrano (ES), Silvia Gonzalez (ES), Santiago Palacios (ES), Damian Dexeus (ES), Cristina Centeno (ES), Javier Cortes (ES), Yann Gaslain (ES)

[Lopez] Hospital Quironsalud, Malaga, [Serrano] Gabinete Medico Velazquez, Madrid, [Gonzalez] Gabinete Medico Velazquez, Madrid, [Palacios] Instituto Palacios de Salud y Medicina de la Mujer, Madrid, [Dexeus] Women Health Institute, Barcelona, [Centeno] Clinica Diatros, Barcelona, [Cortes] Private Practice, Palma de Mallorca, [Gaslain] Procare Health, Barcelona

Context: Papilocare® is a non-hormonal Coriolus versicolor-based vaginal gel. In patients with HPV infection, a regression effect of the LSIL in cervix and a significant virus clearance have been observed after 1-year administration of oral Coriolus versicolor. Objective: To evaluate the efficacy of Papilocare® to repair cervical mucosa in women with HPV-related pap alterations and consistent colposcopy image. Methods: Randomized, open-label, parallel-group, controlled clinical trial. Patients: Currently recruiting 96 positive-HPV women age 30 to 65 with pap result of ASC-US, LSIL or AG-US and concordant colposcopy image. Interventions: Patients are randomized into 3 groups: A) Papilocare® 1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) Papilocare® 1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) no treatment as usual practice. Main outcome measures: Interim analysis of secondary endpoints - changes in epithelialization of the cervix evaluated by standard colposcopy and in perceived stress evaluated by PSS14 - are presented. Papilocare® arms (A+B) were combined for this evaluation. Results: Data from 47 patients at 3 months and 29 at 6 months are available. 20.7% and 47.5% of patients in Papilocare® group vs 22.2% and 16.7% in control group improved the cervix epithelialization at month 3 and 6 respectively (p=ns). At month 3, a trend to stress reduction vs basal was observed in the treatment group (-0.9 points) and was significant at month 6 (-2.9; p=0.045, Student´s t-test). Patients in control group showed a trend to stress increase (+0.5 and +4.7; p=ns) at month 3 and 6, respectively. There were not significant differences between treatment groups. Conclusion: In these interim analysis results, Papilocare® shows a positive trend in cervix epithelialization and a significant stress reduction; these findings need to be confirmed upon study completion.